Hetero Labs Limited Unit V

Complete recall history across all FDA and CPSC categories — 9 total recalls

Hetero Labs Limited Unit V appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (9)

FDA drug safety enforcement actions by Hetero Labs Limited Unit V

Date Product Reason Class
Aug 20, 2018 Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, H... Discoloration: A complaint was received from a pharmacist for the presence of... Class II
Aug 15, 2018 Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero... Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tab... Class I
Aug 8, 2018 Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles,... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... Class II
Aug 8, 2018 Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx On... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... Class II
Aug 8, 2018 Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Onl... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... Class II
Aug 8, 2018 Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx O... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... Class II
Feb 13, 2018 Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured... Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablet... Class II
Feb 13, 2018 Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for C... Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablet... Class II
Dec 22, 2017 Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Cam... Temperature Abuse: Complaints of tablets being wet and stuck together with ta... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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